Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Nephrol. Nov 25, 2021; 10(6): 109-121
Published online Nov 25, 2021. doi: 10.5527/wjn.v10.i6.109
Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis
Piyatida Chuengsaman, Surapong Narenpitak, Suchai Sritippayawan
Piyatida Chuengsaman, Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), Banphaeo 74120, Samutsakhon, Thailand
Surapong Narenpitak, Department of Medicine, Udon Thani Hospital, Udon Thani 41000, Thailand
Suchai Sritippayawan, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Author contributions: All authors contributed in design and oversight of the study, and were involved with data collection at their sites, reviewed the results from statistical analysis and interpretation of the statistic results, read and approved the final manuscript; Chuengsaman P mainly drafted the manuscript.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee, Institute for the Development of Human Research Protections (IHRP), No. IHRP 2365/2556; The Ethics Committee of Udon Thani Hospital, No. 8/2559; and Siriraj Institutional Review Board Faculty of Medicine Siriraj Hospital, Mahidol University, No. Si 588/2016.
Clinical trial registration statement: The study was registered on the Thai Clinical Trial Registry (TCTR), (TCTR ID: 20140128002).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper. Although, Apexcela Co., Ltd. supported for the study funding and medication, the study was conducted and the study results were interpreted without the influence of the pharmaceutical company.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: We did not use CONSORT (for reporting a randomised trial).
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Piyatida Chuengsaman, MD, Doctor, Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), 198 Moo 1 Banphaeo, Banphaeo 74120, Samutsakhon, Thailand.
Received: May 9, 2021
Peer-review started: May 9, 2021
First decision: June 6, 2021
Revised: August 19, 2021
Accepted: September 15, 2021
Article in press: September 15, 2021
Published online: November 25, 2021

Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach.


To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD).


This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36.


All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators’ assessment. At week 12, the QoL scores in all domains were significantly increased from baseline.


Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.

Keywords: Recombinant human erythropoietin, Anemia, Peritoneal dialysis, Chronic kidney disease, Epoetin alfa

Core Tip: This was an open-label, single-arm, prospective, multicenter study of Hema-Plus®, a recombinant human erythropoietin (rHuEPO) for management of anemia in 30 Thai chronic kidney disease patients who started peritoneal dialysis with hemoglobin (Hb) lower than 9.5 g/dL and who had not previously received epoetin. The results showed that the rHuEPO could significantly increase Hb from baseline throughout the 12-wk treatment duration with acceptable safety profile. The quality of life (QoL) scores at week 12 assessed using KDQOL-36 were significantly increased from baseline in all domains.